J&J's Posdinemab Granted FDA Fast Track Designation For Alzheimer's Treatment

(RTTNews) - Wednesday, Johnson & Johnson (JNJ) announced that the FDA has granted Fast Track designation to its Posdinema, a monoclonal antibody being studied for treating early stage Alzheimer's disease in the Phase 2b AuTonomy study.

Fast Track designation will help expedite the review of therapies that treat serious conditions with a high unmet need.

The study has demonstrated potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated Alzheimer's patients. And also found to be blocking the development and spread of tau aggregates in non-clinical models of disease.

Bill Martin, Global Therapeutic Area Head, J&J Innovative Medicine said, "Posdinemab has the potential to slow the spread of tau pathology in the brain - which may slow cognitive decline."

Previously, in July 2024, JNJ-2056, the company's first active immunotherapy targeting tau, had also received Fast Track designation.